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NCT Number: NCT02238080

An Observational Study of Methoxy Polyethylene Glycol-Epoetin Beta (Mircera) in Chronic Kidney Disease Participants on Dialysis

This observational, multi-center, open-label, prospective study will evaluate the relationship between serum interleukin-6 (IL-6) and C-reactive protein (CRP) levels and methoxy polyethylene glycol-epoetin beta dosage in participants with chronic kidney disease (CKD) on dialysis. Participants will be recruited who are on stable methoxy polyethylene glycol-epoetin beta maintenance therapy or will initiate therapy with methoxy polyethylene glycol-epoetin beta.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haemek Hospital; Nephrology, Afula, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CKD participants undergoing dialysis
  • Participants initiating ESA treatment with methoxy polyethylene glycol-epoetin beta or participants on stable methoxy polyethylene glycol-epoetin beta maintenance therapy
  • Adequate iron status defined as: serum ferritin above or equal to 100 micrograms per liter (mcg/L) or transferrin saturation above or equal to 20 percent (%)

Exclusion criteria

  • Conditions known to cause inadequate response to ESA treatment
  • Anemia other than symptomatic anemia associated with CKD

Treatment and study plan

methoxy polyethylene glycol-epoetin beta

Drug

Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.

Other names: Mircera®

Primary outcomes

  1. Correlation Coefficient (r) Between Serum C-Reactive Protein (CRP) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose

    Time frame: Day 1

    Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

  2. Correlation Coefficient (r) Between Serum Interleukin-6 (IL-6) Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose

    Time frame: Day 1

    Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

Secondary outcomes

  1. Percentage of Participants With Change in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

    Time frame: Month 6

    Percentage of participants with change in methoxy polyethylene glycol-epoetin beta dose compared to baseline were reported as per the following categories: (a) No change, (b) Dose increase (1 to greater than [>] 200 micrograms per kilogram [mcg/kg]), and (c) Dose decrease (1 to >200 mcg/kg).

  2. Change From Baseline in Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

    Time frame: Baseline, Month 6

  3. Serum CRP Level

    Time frame: Baseline, Month 6

  4. Serum IL-6 Level

    Time frame: Baseline, Month 6

  5. Correlation Coefficient (r) Between Serum CRP Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

    Time frame: Month 6

    Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

  6. Correlation Coefficient (r) Between Serum IL-6 Level and Methoxy Polyethylene Glycol-Epoetin Beta Dose at Month 6

    Time frame: Month 6

    Regression analysis and Pearson correlation were used to calculate the correlation coefficient (r).

  7. Predictive Baseline Serum CRP Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose

    Time frame: Day 1

  8. Predictive Baseline Serum IL-6 Level for Participants Initiating Treatment With Methoxy Polyethylene Glycol-Epoetin Beta Dose

    Time frame: Day 1

  9. Serum Hemoglobin Level

    Time frame: Baseline, Month 6

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Inflammatory Markers and Mircera® Prospective Assessment of Correlation (IMPACT): A Multi-Center Observational Study Investigating the Correlation Between Inflammatory Marker Levels and ESA Dosage in CKD Patients on Dialysis Treated With Mircera®

Acronym: IMPACT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Sep 12, 2014
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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